GRAS Act

Under current law, substances added to food generally must be approved by the FDA before use. However, substances that are generally recognized as safe (GRAS) by qualified experts are exempt from premarket review. Manufacturers may, but are not required to, notify the FDA when they determine a substance is GRAS.

Under the bill, a new substance (or a new use of an existing substance) may not be treated as GRAS and used in food until the FDA is notified of the determination that the substance is GRAS and issues a written statement that it does not object to that determination. The notification must detail the conditions under which the substance has been determined to be GRAS and must include specified supporting information, including evidence that the substance is not toxic or carcinogenic. The FDA must seek public comment on GRAS notifications and must act on notifications within a specified period.

Further, the FDA must regularly reassess the safety of certain substances used in food, including substances considered GRAS before the bill's enactment, and may require the submission of safety information for substances being reassessed.

Finally, the bill establishes fees for initial FDA review of substances used in food and for safety reassessments.